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Trial record 1 of 1 for:    NCT00305903
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Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305903
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : December 21, 2007
Information provided by:

Brief Summary:
This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Rivastigmine, memantine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)
Study Start Date : March 2006
Actual Study Completion Date : August 2007

Primary Outcome Measures :
  1. Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)

Secondary Outcome Measures :
  1. Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a diagnosis of probable Alzheimer's disease;
  • Have an MMSE score between 10 and 20;
  • Must be able to swallow capsule/tablet;
  • Must have a caregiver who is able to attend all study visits;

Exclusion Criteria:

  • Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
  • Have a current diagnosis of active, uncontrolled seizure disorder;
  • Have a history within the past year or current diagnosis of cerebrovascular disease
  • Have a current diagnosis of severe or unstable cardiovascular disease;
  • Had a myocardial infarction (MI) within the last six months;
  • Have specific respiratory, digestive, renal, or endocrine disorders;
  • Have had previous treatment with rivastigmine or memantine;

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305903

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United States, New Jersey
Manchester, New Jersey, United States, 08759
Sponsors and Collaborators
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Study Chair: Novartis 862-778-8300
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00305903    
Other Study ID Numbers: CENA713BUS32
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents